Gardasil – The Grim Reaper – Mounting Injuries Last as Long as Vaccine Efficacy
By Leslie Carol Botha
April 25, 2011
PR Log
FOR IMMEDIATE RELEASE
PRLog (Press Release) – Apr 25, 2011 – It is becoming hard to comprehend why the United States government; FDA, CDC and the NCI have blatantly turned their backs on the thousands of families whose daughters and sons have been severely injured by Merck’s Gardasil vaccination. GlaxoSmithKline is not off the hook on this either as mounting injuries from Cervarix (approved in the US in 2009) are now being reported to VAERS. How many deaths and how many injuries is it going to take before these vaccines are taken off the market?
The latest VAERS reports include:
• 376 abnormal pap smears post HPV vaccination
• 108 reports of anogenital warts found after HPV vaccination
• 224 reports of papillomavirus infections found after HPV vaccination
• 41 reports of cervical cancer after HPV vaccination
• 21,634 Adverse Events
• 95 Deaths
The numbers reflect approximately, 1 to 10% of the adverse event population reporting. Medical consumers and physicians do not often think that vaccinations harm people – and therefore injuries and illnesses are not immediately associated with the vaccine.
HPV vaccines have been administered to adolescent girls and boys whose parents believed in the government’s vaccine program. They followed their physician’s advice – and have been deceived. What does that say about a government ‘for the people’?
SANE Vax, Inc. is outraged at the injustice shown to these families who now suffer from loss of life or diminished quality of life; outraged by their financial helplessness as they pay for mounting medical bills not covered by health insurance companies.
It is apparent in this country – the only one’s innocent until proven guilty are the government and corporations – who have protected themselves from liability. For the rest of us – well, we are guilty until proven innocent – and the burden of proof lies on our shoulders.
SANE Vax, Inc. has prepared a Global Concerns about HPV Vaccines Fact Sheet that includes the peer reviewed analysis, research documents and data that prove the culpability of Merck, GlaxoSmithKline, the CDC, FDA, and NCI in regards to fast tracking the HPV vaccines to medical consumers. The SANE Vax Team believes it is time to hold them accountable for their actions. The Fact Sheet is posted on the SANE Vax, Inc. web site at http://sanevax.org/news-blog/2011/04/sanevax-presents-gl …
The HPV Vaccine Fact Sheet was created so that it could be shared globally with politicians, physicians, the media and anyone looking for an overview of the concerns about the Gardasil and Cervarix travesty.
We are hoping readers will post the fact sheet to their Social Media Network sites and circulate the fact sheet far and wide. If we cannot get through to our government – then we, the people, need to make it our responsibility to educate other innocent medical consumers to prevent the Grim Reaper from striking down more innocent adolescents.
SANE Vax Inc. is dedicated in our efforts to remove Gardasil and Cervarix from the market until independent studies on their safety and efficacy are conducted. We have become internationally recognized and known for the research and work we have done on this issue. Conversely, we are now being contacted by more mothers whose daughters have been adversely affected by HPV vaccines. Most of these injuries have not been reported to VAERS. We have even heard of a new death – another previously healthy teenage girl who went to bed on a Sunday night and never got up to go to school the next morning.
Read the comments from mothers and other innocent girls affected by HPV vaccines. The government and Big Pharma must be held accountable for the innocent lives they have destroyed. Government agencies and pharmaceutical companies have become the Grim Reaper.
“My 15 year old autistic daughter was given all three Gardasil injections in 2009, and hasn’t been well since. She’s struggled her entire life with development delay, OCD, stuttering, and a seizure disorder that hasn’t reared its head since she was 9, so we’re not unfamiliar with hardships. Shortly after her last Gardasil injection, she began to have chronic vaginal itching, low grade fevers, severe headaches, abdominal pains, dizziness, leg pains, heart racing, heightened sense of her heartbeat and blood flow, fatigue, and an overall feeling of illness. I’m sure there are other symptoms that I’ve passed off as growing pains, hormones, you name it. I’m relieved to find this group, and join the ranks as another frustrated, determined mother, who is ready to see the makers and distributors of this “vaccine” be accountable for what they have done to our daughters.”
“My daughter who has just turned 14 years old has been unable to attend school due to fatigue and nausea and other symptoms since last December 2010. When I took her to her G.P. and had all the usual blood tests done they returned as normal. I did mention to the doctor that my daughter had had her second HPV injection at school just before she began to feel sick, but she dismissed any connection. The third vaccination injection is due this Thursday and I have decided to not allow my daughter have this final injection. Is this o.k. for her not to complete the vaccination programme as I am now suspecting that there may be a connection between the vaccination and her illness? My daughter has just started back to school this week after an absence of over three months. She is attending for only a few hours per day as she is too fatigued to manage any more than that.”
“I just had an MRI completed for my lower lumbar spine; I had a minor sports injury. Results read “bladder distention was noted.” I completed my Gardasil vaccine over a year and a half ago, and two months after started noticing extra pressure and pain in my abdomen, and enlarged lymph nodes. Prior to the vaccine, I never experienced any of my “symptoms” and Gardasil is the biggest regret of my life. It was pushed upon me by my 3 doctors for years, promising it was safe, and there were no side effects associated. After I started complaining about tiredness and abdomen pain, major side effects were being brought to my attention. I feel deceived, lied to, and tricked. I experience discomfort and occasional pain when I am intimate with my partner. I have trouble urinating, and urinate frequently now. I am 24 years old, and devastated about my experience and findings. I am depressed and fearful of other complications it may cause in the future and can only be hopeful that I didn’t damage and will not pass on any complications to a child.”
“I am writing to u because I was also affected by Gardasil. I now have limbic encephalitis, which is the swelling of the brain, along with heart palpitations which don’t let me sleep, extremely bad headaches, body pain every morning, bone problems, anxiety problems, the list goes on forever. If you can please contact me, I would really appreciate it.”
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
Wednesday, April 27, 2011
Saturday, April 9, 2011
SANE Vax, Inc. Declares Major Victory in Gardasil Awareness Campaign
In a long awaited decision(1), the US FDA has ruled against Merck's supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. This was Merck’s 4th request to expand Gardasil use to an older population of women.
SANE Vax, Inc. applauds the FDA on their decision. According to Norma Erickson, President, "This decision is a major victory for medical consumers around the world. I would like to personally thank the SaneVax Team as well as each one of the medical professionals, scientific researchers and educators who have helped get the truth behind the development, testing, approval and marketing of this vaccine out to the public. All of their hard work is empowering medical consumers worldwide to say, "Enough is enough! If it is not Safe, Affordable, Necessary and Effective - we don't need it!"
Leslie Carol Botha, Vice-President of Public Relations for SANE Vax, Inc. made this statement: “it is obvious the SANE Vax Gardasil Awareness Media Campaign has been effective. We have communicated our concerns to the FDA on multiple occasions using science based peer reviewed analysis, and at the same time we have written and distributed hundreds of press releases and articles documenting not only the research but the damage Gardasil has done to previously healthy adolescents. We can proudly say medical consumers, and doctors, as well as our government are paying attention to our concerns.
FDA Ruling an Admission of Guilt?
A press release issued by Merck on April 6, states that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.”(2)
SANE Vax Inc., believes Gardasil has not been demonstrated to prevent CIN 2/3 or worse in women younger than 26 years old either. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.
SANE Vax, Inc. will continue our campaign until Gardasil is taken off the market.
On October 25, 2010 SANE Vax Inc., issued a Business Wire press release asking the FDA to rescind approval of Gardasil because of “Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation” following formal letters sent to Margaret Hamburg, FDA Commissioner, and former Chair of VRBPAC, Jack Stapleton.
In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, President of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use “CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer.”(3)
In the press release “Erickson pointed out that in the natural history of cervical cancer development only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions; and only a small fraction of CIN 3 lesions will progress to cervical cancer. Therefore, there are many more CIN 2 lesions than CIN3 lesions and cervical cancers combined in any female population, including the subjects enrolled in the Gardasil™ clinical trials. As a result, the overwhelming majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil™ HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC Meeting must have been CIN 2 lesions.
Erickson quoted a scientific report in which the National Cancer Institute (NCI), the inventor of the HPV vaccine technology and co-developer of Gardasil™, concluded "CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less-than-perfect representation of the underlying disease state. That CIN 2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error...”
Consequently, the FDA has allowed Merck & Co., Inc. to market Gardasil™ as a cancer vaccine, when in fact it has only been proven to prevent “not a true biologic entity”- a reversible CIN2 change.” (2)
SANE Vax Inc. believes the FDA has opened the door to formally question the validity of the end point utilized in Merck’s initial Gardasil clinical trials. The shadow of doubt has been cast – but not until after the vaccine caused severe damages and untimely deaths to the very population Gardasil was designed to protect.
Sources:
1. Expand or Not Expand–That's the Question/Will FDA Approve Merck’s 4th Request to Expand Gardasil - visit http://www.prlog.org/11126388-expand-or-not-expandthats-the-questionwill-fda-approve-mercks-4th-request-to-expand-gardasil.html for more info
2. U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women - visit http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html?WT.svl=content&WT.pi=content+Views for more info
3. S.A.N.E. Vax, Inc. Asks FDA to Rescind Approval of Gardasil™: Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation - visit http://www.businesswire.com/news/home/20101025005268/en/S.A.N.E.-Vax-Asks-FDA-Rescind-Approval-Gardasil%E2%84%A2 for more info
4. visit http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/default.htm for more info
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
SANE Vax, Inc. applauds the FDA on their decision. According to Norma Erickson, President, "This decision is a major victory for medical consumers around the world. I would like to personally thank the SaneVax Team as well as each one of the medical professionals, scientific researchers and educators who have helped get the truth behind the development, testing, approval and marketing of this vaccine out to the public. All of their hard work is empowering medical consumers worldwide to say, "Enough is enough! If it is not Safe, Affordable, Necessary and Effective - we don't need it!"
Leslie Carol Botha, Vice-President of Public Relations for SANE Vax, Inc. made this statement: “it is obvious the SANE Vax Gardasil Awareness Media Campaign has been effective. We have communicated our concerns to the FDA on multiple occasions using science based peer reviewed analysis, and at the same time we have written and distributed hundreds of press releases and articles documenting not only the research but the damage Gardasil has done to previously healthy adolescents. We can proudly say medical consumers, and doctors, as well as our government are paying attention to our concerns.
FDA Ruling an Admission of Guilt?
A press release issued by Merck on April 6, states that: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.”(2)
SANE Vax Inc., believes Gardasil has not been demonstrated to prevent CIN 2/3 or worse in women younger than 26 years old either. Clinical trials used an endpoint insufficient to clearly demonstrate efficacy in this arena. Therefore, we believe that Gardasil needs to be taken off the market until an independent study on the vaccine’s safety and efficacy is conducted.
SANE Vax, Inc. will continue our campaign until Gardasil is taken off the market.
On October 25, 2010 SANE Vax Inc., issued a Business Wire press release asking the FDA to rescind approval of Gardasil because of “Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation” following formal letters sent to Margaret Hamburg, FDA Commissioner, and former Chair of VRBPAC, Jack Stapleton.
In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, President of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use “CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer.”(3)
In the press release “Erickson pointed out that in the natural history of cervical cancer development only a small fraction of the CIN 2 lesions will progress to CIN 3 lesions; and only a small fraction of CIN 3 lesions will progress to cervical cancer. Therefore, there are many more CIN 2 lesions than CIN3 lesions and cervical cancers combined in any female population, including the subjects enrolled in the Gardasil™ clinical trials. As a result, the overwhelming majority of the “CIN 2/3 or worse” cases used for evaluation of efficacy and listed in the VRBPAC Background Document on Gardasil™ HPV Quadrivalent Vaccine presented at the May 18, 2006 VRBPAC Meeting must have been CIN 2 lesions.
Erickson quoted a scientific report in which the National Cancer Institute (NCI), the inventor of the HPV vaccine technology and co-developer of Gardasil™, concluded "CIN 2 is not a true biologic entity but an equivocal diagnosis of pre-cancer, representing an admixture of HPV infection and pre-cancer. The existence of CIN 2 biopsy results as a clinical entity may be the consequence of the inaccuracies of colposcopy and colposcopically directed biopsy, which could result in less-than-perfect representation of the underlying disease state. That CIN 2 is the least reproducible of all histopathologic diagnoses may in part reflect sampling error...”
Consequently, the FDA has allowed Merck & Co., Inc. to market Gardasil™ as a cancer vaccine, when in fact it has only been proven to prevent “not a true biologic entity”- a reversible CIN2 change.” (2)
SANE Vax Inc. believes the FDA has opened the door to formally question the validity of the end point utilized in Merck’s initial Gardasil clinical trials. The shadow of doubt has been cast – but not until after the vaccine caused severe damages and untimely deaths to the very population Gardasil was designed to protect.
Sources:
1. Expand or Not Expand–That's the Question/Will FDA Approve Merck’s 4th Request to Expand Gardasil - visit http://www.prlog.org/11126388-expand-or-not-expandthats-the-questionwill-fda-approve-mercks-4th-request-to-expand-gardasil.html for more info
2. U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women - visit http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html?WT.svl=content&WT.pi=content+Views for more info
3. S.A.N.E. Vax, Inc. Asks FDA to Rescind Approval of Gardasil™: Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation - visit http://www.businesswire.com/news/home/20101025005268/en/S.A.N.E.-Vax-Asks-FDA-Rescind-Approval-Gardasil%E2%84%A2 for more info
4. visit http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/default.htm for more info
# # #
SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.
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